Fact Check Finds Serious Flaws in ADA Report Concerning ... · CDEL FAQ – FACT CHECK Page 3 on...
Transcript of Fact Check Finds Serious Flaws in ADA Report Concerning ... · CDEL FAQ – FACT CHECK Page 3 on...
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FactCheckFindsSeriousFlawsinADAReportConcerningSedationDentistry
TheAmericanDentalAssociationanditsCouncilonDentalEducationandLicensureissuedareport–“FrequentlyAskedQuestions–Resolution37”–designedtoinformADAmembersanddelegatesofthefactspertainingtoResolution37,aproposedrevisiontotheADA’sSedationandAnesthesiaGuidelines.WhatfollowsisasummaryofCDEL’sFAQandaFactCheckpreparedbyagroupofscientists,academics,anddentists–allADAmembers–whoareindependentofCDEL.Q.1.WhatwastheCouncil’sresponsetothedirectivesofthe2015HouseofDelegates?
CDEL’sCLAIMS:
• TheCouncilreliedonadetailedreport,titled“ReportontheRisksandBenefitsofUsingCapnographyinDentalPatientsUndergoingModerateSedation,”preparedatitsrequestbytheADA’sCouncilonScientificAffairs(CSA).
• TheCouncil“alsoconsideredcommentsreceived…”
THEFACTS:
The2015ADAHouseofDelegatesadoptedResolution77H,whichcalledonCDELtowork“incollaboration”withCSAtoconsiderthreeissuesembodiedinwhatisnowcalledResolution37.
1. AllowingdentiststohaveachoiceofoptionswhenitcomestomonitoringendtidalCO2formoderatesedation,“suchas:continuoususeofaprecordialorpretrachealstethoscope,continuousmonitoringofendtidalcarbondioxide,andcontinualverbalcommunicationwiththepatient.”
2. Therecommendedhoursandcontentofmoderatesedationcourses,includinga“possibleoptionofseparatecourserequirementsforenteralandparenteralroutesofsedation.”
3. TherationaleandguidelinesfortheuseofBodyMassIndexinconductingpatientevaluations,andthetimingofmedicalhistoryreview.
CONCLUSION:ThereissubstantialevidencethatCDELandCSAdidnotfulfillthe2015HouseofDelegatesmandate
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EVIDENCE:
• InitsFAQ,CDELpresentssummarizedevidencefromCSA’s“ReportontheRisksandBenefitsofUsingCapnographyinDentalPatientsUndergoingModerateSedation.”CDEL’spresentationincludeswhatitdescribesasthekeysummarystatement:“theevidencedemonstratesthatcapnographyinconjunctionwithstandardmonitoringimprovedsensitivityofdetectingadverserespiratoryeventsandreducestheriskofhypoxemiaduringmoderatesedationcomparedwithstandardmonitoringalone.”
CDELdoesnotrespondtothe2015HODresolutioncallingforCDELtoweighoptionsfordentistsotherthancapnography,suchasaprecordialorpretrachealstethoscope,whichmaybeequallyassafeandeffectiveascapnography,andpreferredbymanydentistsfortheireaseofoperationandcostsavings.
• EventhetitleoftheCSAreport,“RisksandBenefitsofUsingCapnography…”makesitabundantlyclearthattherisksandbenefitsofsuggestedalternativestocapnographywerenotreportedand,perhaps,notconsideredasmandatedbythe2015HOD.
• Whilethe2015HODmandatedthatCDELconsultwithCSAonthequestionofhowmanyhoursoftrainingformoderatesedationshouldberequired,andwhatthecontentofsuchtrainingshouldconsistof,neitherCDELnorCSAindicatethatanysuchcollaborationtookplace.Likewise,CSA’sownreportstotheADAofitsactivitiesincludesnomentionthatitwasconsultedandprovidedanopinionastothepossibleoptionofseparatecourserequirementsforenteralandparenteralroutesofsedation.
• DiscussingResolution37’sprovisionsforconsistentpatientevaluation
provisionsandtherationaleandguidelinesfortheuseofBodyMassIndex,CDEL’smakeszeromentionofconsultingwithCSAonthematter.Indeed,CDELcitesonlyitself,itsbeliefs,anditsinternaldiscussions–ignoringthe2015HODmandatethatitcollaboratewithCSA.Onceagain,inCSA’sownreportstotheADAofitsactivitiesprovidesnomentionthatitwasconsultedandprovidedanopiniononthisissue.
• AspartofthepubliccommentssubmittedtotheADApertainingtoResolution37,PamelaPorembskiD.D.S.,whoisthedirectoroftheADA’sCouncilonDentalPracticeinthePracticeInstitutesubmittedcomments
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onbehalfofamemberoftheCouncilonDentalPracticeonJuly7,2016:“Inmyopinion,andtheopinionofotherdelegates,thisadoptedresolution[HODResolution77H–2015]callsforevidencethatCSAhasstudiedtheavailablescience,literatureanddocumentationofallthreebulletpointsandhasmadeappropriateandscientificdeliberationtoCDELfortheirdeliberation…
“Giventheavailableevidence,thethreedocumentssubmittedtousfromCDEL,onecanonlyconcludethatCDELhasnotfulfilleditsmandateassetforthbythe2015HouseofDelegates.”
• InitsownFAQ,CDELacknowledgesinresponsetoQuestion#8:“…not
onecontrolledclinicalstudyhaseverbeenperformedtodemonstratetheoptimaltrainingtimefordentistswhoprovidemoderatesedation.”
• TheADA’spublishedpolicyonEvidence-BasedDentistry(EBD)isunambiguous:Evidence-based dentistry is an approach to oral health care that requires the judicious integration of systematic assessments of clinically relevant scientific evidence, relating to the patient's oral and medical condition and history, with the dentist's clinical expertise and the patient's treatment needs and preferences. ADAResolution37lacksbothevidence-basedsciencetosupportitsproposedrevisions,aswellastheclinicalexpertiseofdentists.ThevastmajorityofdentistsonbothADACouncils,CDELandCSA,donotusemoderatesedationtotreattheirpatientsandthushavelittleifanydirectexperiencewiththemethod.
Q.2.Whydoestheproposedguidelinenotoutlinetrainingbyrouteofadministration?
CDEL’sCLAIMS:
• TheCouncilcarefullystudiedthismatterandmaintainsthat“moderatelysedatedpatientsviaeitherrouterequirethesameattentivenessandmonitoring;thereshouldbenodifferenceinthetrainingrequirementsrelatedtoroutesofadministration.”
• AreviewofCEcourseswasconducted:atleast11providerscurrentlymeetorexceed60hoursofinstructionand20patientexperiences.
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THEFACTS:
• TheADAhaspledgedtosetitspracticeandeducationalguidelinesbasedonevidenceandscience.
“Thepracticeofevidence-basedmedicinemeansintegratingindividualclinicalexpertisewiththebestavailableexternalclinicalevidencefromsystematicresearch,”theADAstatesinitspublishedpolicystatement.Carefulstudyofthematter–whichCDELassertsasitsjustificationforconcludingthat“thereshouldbenodifferenceinthetrainingrequirementsrelatedtoroutesofadministration”–fallsfarshortofconstitutingevidence-basedsubstantiation.(NotethatthevastmajorityofCDELmembersdonotprovidemoderateenteralsedationtotheirpatients.)Dentalresearchersandscientistswhohavepublishedonthetopicof“routeofsedation”haveconsistentlyconcludedtheexactoppositeofCDEL’scontention:Therearescientificallydemonstratedcrucialdifferencesintheresponseofpatients,andthusthesafetyprecautionsandnecessarytraining,whendentistsuseenteralversusparenteralroutesofsedation.See:http://GetTheScience.comtoreviewjustsomeofthepublished,peer-reviewedarticlesonthistopic.CDELdoesnotprovidecitationsandreferencestopublished,peer-reviewedstudiesthatsupportitscontentionandconclusions.
• Resolution37effectivelyblursthelinesbetweenminimalsedationascurrentlydefined,andmoderatesedation.Asaresult,evendentistswhoconfinetheirpracticestoprovidingminimalsedationmayberequired–inordertofullycomplywiththeguidelinesproposedinResolution37–toundergo60hoursofIVsedationtraining.
• WedonotknowwhatmethodCDELusedtoassertthat“atleast11providerscurrentlymeetorexceed60hoursofinstructionand20patientexperiences.”[Threeofthe11CEcourseproviderslistedbyCDELdonotlistIVsedationcourses:UniversityofAlabamaatBirmingham,AugustaUniversity,andDOCSEducation.]
CDEL’sassertionseemsillogicalonitsfacesincecurrentADAguidelinespertainingtotrainingformoderateenteralsedationcallforonly24didactic
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hoursand3patientexperiences(alongwithtenclinicalexperiences,ofwhichsevencanbevideos.)
CDELseemstobereferringtoexistingeducationalprogramsaimedexclusivelyatlicensingrequirementsfordentistswhowillprimarilyprovideparenteralsedation.Therearefewerthan150seatsperyearavailablenationwidetodentistswhoseektoacquiresuchparenteralsedationtraining.Therearenoknowncoursesofferedbyanycredibleeducationalinstitution,for-profitornonprofit,thatprovide60hoursofdidactictrainingand20livecasestothosedentistswishingonlytobecertifiedtoprovidemoderateenteralsedation.ShouldResolution37beapprovedbythe2016ADAHOD,the8(verified)parenteralCEcoursesthatCDELcites–basedoncurrentenrollmentcapacity–wouldrequireapproximately200yearstocertifythemorethan30,000dentistswhocurrentlyadministerenteralmoderatesedation,andtheirsuccessors.
[ForMore,SeeQuestion#7andtherelatedFACTCHECK.]
CONCLUSION:TherecommendationsofCDELdonotcomportwiththeADA’sPolicyonEvidence-BasedDentistry,lackingpeer-reviewed,science-backedsubstantiation,orclearclinicalevidence.ShouldCDEL’srecommendationsbeadoptedbytheADA2016HOD,therewillnotbenearlyenoughcoursestomeetthedemandofdentistswhowillneedtobecertifiedascompetenttoadministermoderateenteralsedation.
Q.3.Whyistheconcomitantadministrationoftwodifferentoralmedicationsconsideredmoderatesedation?
CDEL’sCLAIMS:
• TheCouncilstatesthatpotentiationcreatesaneteffectthatisgreaterthantheMRDofeachdrugalone.Itcitesthe2012ADAGuidelinesforTeachingPainControlandSedationtoDentistsandDentalStudents,whichstatethatgivingenteraldrugsabovetheMRDisconsideredmoderatesedation.“Therefore,exceedingtheMRDisalreadyconsideredtobemoderatesedation.”CDELsaysitcouldfindonlythreepublishedpapersrelatedtopotentiationand
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oralsedation:from1986,2007,and2009.Twoofthethreepaper’sofferindirectsupportforitsposition.
THEFACTS:
• CDELagainfailstoadheretotheADA’sownpolicyonevidence-baseddentistry,whichclearlystatesthatintheabsenceofsufficient“clinicallyrelevantscientificevidence,”itmustrelyon“thedentist’sclinicalexperienceandthepatient’streatmentneedsandpreferences.”The1986,2007,and2009studiesareinsufficienttojustifytheproposedchangesembodiedinResolution37,whichCDELtacitlyacknowledges.YetCDELentirelyignorestheextensiveclinicalevidencethatspeakstothedemonstratedsafetyandefficacyofusingpotentiationincompliancewithexistingADAguidelines,meetingtheneedsandpreferencesofliterallymillionsofdentalpatients.ShouldResolution37beapprovedbythe2016HOD,theimpactonroutinedentalprocedureswouldbeunquantifiable.Beforeadentistcouldadministerapatienttwodrugsofanytypeandpotency,thedentistwouldhavetoreceivetheequivalentofanIVsedationpermit:i.e.aminimumof60hoursofinstructionandatleast20individually-managedpatients.CONCLUSION:AdoptingResolution37anditsrestrictionsontheadministrationoftwodifferentoralmedicationswithoutextensiveadditionaltraining,violatestheADA’spolicytoactinaccordancewiththe“patient’streatmentneedsandpreferences.”Thescientificjustificationformakingitmuchharderfordentiststousepotentiation–currentlyawidespreadpractice–isskimpyatbest.
Q.4.Howdothe2016proposedGuidelinesdifferfromtheversionconsideredbythe2015ADAHouseofDelegates?
CDEL’sCLAIMS:
• TheCouncilstatesthat2015’sResolution77and2016’sResolution36arevirtuallyidentical.Themainexceptionisthatthe2016proposedrevisionseliminatereferencestosedationandanesthesiaforchildren.CDELandtheADAdeferexclusivelytotheguidelinessetbytheAmerican
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AcademyofPediatricsandtheAmericanAcademyofPediatricDentistry(AAPD).
THEFACTS:
• CDELfailstoofferanexplanationforthischange.CDEL’sabdicationofresponsibilityforprovidingitsownpediatricguidelinesraisesimportantunaddressedquestions:1. TheAAPD’sguidelinesgivedentiststheoptionofmonitoringsedation
patientsusingcapnographyorprechordialauscultation.Whythen,doesCDELinsistonmorestringentmonitoringregulationsforadults(capnography)thanitdoesforchildren,whoaregenerallyatgreaterrisk?IfCDELisseriousaboutprotectingpublicsafety,shouldn’tthatapplytoallmembersofthepublic,regardlessoftheirage?
2. Manygeneralpractitionersprovidepediatricsedation,yetarenotmembersofAAPDandhavenotcompletedaPediatricresidency.CDELandResolution37leaveADAgeneraldentalmemberswithoutpediatricsedationguidance.Why?
3. TheCDELproposalmuddiesthewaterwhenitcomestothedefinitionof“children.”Whatageisachildforthepurposesofdentaltreatments?TheADApreviouslydefinedachildas13yearsoryounger.Ithasrescindedthatdefinition.CDELandtheADAnowpuntthequestionofagetotheAAPD,whichinturn,basesitsdefinitionontheAmericanAssociationofPediatrics’(AAP)definition.AAPdefinesachildasanyoneunder21yearsofage.Assuch,isa20-year-oldpatienta“child,”andifso,mustgeneraldentistsnowobtainPALScertificationinadditiontoACLSformoderatesedation?CDELismumonthesequestions.
CONCLUSION:LiketheexplanationforvirtuallyeverycomponentofResolution37,politicalposturing–notscience–appearstobethesolemotivationforCDEL’sdecisiontoallowtheAAPDtosetallguidelinesforpediatricsedation.CDELdoesnotevenfeignascience,evidence-based,orclinicalrationaleforallowingdentistsflexibilitywhenitcomestotheirchoiceofmethodsformonitoringsedatedchildren(capnographyorprechordialauscultation),butnotadults.
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Q.5.InwhatwayswerethedentalanesthesiologycommunitiesnotifiedthattheGuidelineswereunderrevision?Wasthereanopportunitytocommentontheproposal?
CDEL’sCLAIMS:
• TheCouncilnotesthatitheldateleconferenceofferingin-personandphonedopportunitiestotestifyonApril21,2016.Italsoprovidedtwowrittencommentperiods.Theteleconferenceandcommentopportunitieswerepromotedviamultiplechannels,includingdirectemailnotification.CDELlists18dentalanesthesiologycommunitiesofinterestasthosethatwerecontactedandinvitedtoparticipate.Atotalof33writtenandoralcommentswerereceivedand“systematicallyreviewedbytheCouncil.”
THEFACTS:
• CDELoffersnoexplanationforwhytheonlycommunitiesofinterestthatitcontactedwere“anesthesiologycommunities.”Certainly,thosecommunitiesneededtobeincluded.YetthecommunitythatwillbemostgreatlyimpactedifResolution37isapproved,namelypatients,wasnotnotifiedofthehearingorcommentperiods,andwasnotinvitedtoshareitsviews.AstheADA’s“PolicyonEvidence-BasedDentistry”makesclear,thetreatmentneedsandpreferencesofpatientsmustbeconsideredwhenestablishingpracticeguidelines.Forthesecondconsecutiveyear,CDELundertooknostudytodeterminetheimpactResolution37wouldhaveonpatients,patientsatisfaction,andaccesstocare.[ForMore,SeeQuestion#12andtherelatedFACTCHECK.]TheADA’smissionistobepatient-centered,workingforthe“improvementoforalhealthforthepublic.”YetthepublicwasdecidedlyexcludedfromCDEL’sdeliberations.
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• CDELprovidesnodetailsaboutitssystematicreviewandhowitwasconducted.WereallrespondentstreatedequallyordidtheCouncilgivemorecredencetosomegroupsandlesstoothers?
Ofthe18groupsinvited,oneinparticular,AcademyofGeneralDentists(AGD),representsthelargestnumberofdentistswhoarelikelytofeeltheimpactofResolution37,shoulditbeapprovedbythe2016HOD.AGDmembersnumbermorethan40,000,andaftertheADAitself,AGDisthelargestdentalassociationintheUnitedStates.TheAGDstronglyopposesResolution37andtheadditionalburdensitwouldplaceonitsmembersandpatients.AGDtestifiedtothatandsubmitteddetailedwrittencommentstoCDEL.AGDmembersregularlyusemoderateenteralsedationinthetreatmentoftheirpatients,unlikemostothermembersofCDEL’scommunitiesofinterest.CDELdoesnotdisclosehowits“systematic”reviewofthetestimonyandwrittencommentsofthecommunitiesofinterestweighedtheAGD’scommentsandthevastclinicalexperiencerepresentedbyAGDmembersversus,forexample,theargumentsoftheAmericanAssociationofDentalBoards,theAmericanSocietyofAnesthesiologists,orStateBoardsofDentistry–alsoconsideredbyCDELcommunitiesofinterest.[ForMore,SeeQuestion#8andtherelatedFACTCHECK.]ItshouldbenotedthatwhilemostmembersofCDELarealsomembersoftheAmericanAssociationofOralandMaxillofacialSurgeons(AAOMS),whichstronglysupportsResolution37,AAOMSisnotlistedamongthecommunitiesofinterestthatCDELcontacted.
CONCLUSION:Cosmetically,CDELmadeanefforttosolicitthecommentsandtestimonyofexpertsonthetopic.Butsomeofits“experts”werefarlessinformedonthetopic–andrepresentedfarlessclinicalexperiencewithsedationdentistry–thanothers.
Importantly,CDELrepeatedits2015postureintotallyexcludingpatientsfromitscommunitiesofinterestandfailingtomakeevenacosmeticattempttostudythepracticalandfinancialimpactthatResolution37,ifapproved,willhaveonpatientsandtheiraccesstocare.
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Q.6.Manydentistsholdsedationpermitsissuedbyastatedentalboard.Aredentists’sedationpermitsinjeopardyiftheproposedrevisedADAGuidelinesareadopted?
CDEL’sCLAIMS:
• TheCouncilmaintainsthatthestatelegislaturesanddentalboardsalonehavetheauthoritytoestablishpermit/licenserequirementsbywhichdentistswithanesthesiapermitsorlicensesmustabide.“Thestateboardsdeterminetherequirementsfordentistswhoadministersedation,nottheADA.”
THEFACTS:
• CDEL’sanswerisdisingenuousatbestandmorelikely,outrightdeception.Inmanystates,theADAguidelinesarepartoftheregulatorylanguage,sotheyautomaticallybecomegoverninglaw.Inotherstates,itisallbutaforegoneconclusionthatthedentalboardwillembracetheADAguidelinesandthelegislaturewillvotethemintolaw.ThetruthfulansweristhatifResolution37isapprovedbythe2016HOD,withinafewyears,thousandsortensofthousandsofdentistsnationwidewillberequiredbylawtoobtainnew,stricter,sedationpermitsorsimplystopofferingmoderateenteralsedationtotheirpatients.
CONCLUSION:WhiletheADA,technically,doesnotsetstatestandardsforthosewhoadministersedationandanesthesia,itsguidelines,asadoptedbytheHOD,dobecomelawalmostautomaticallyinmorethanhalfofthestates.ManythousandsofdentalpermitswillbeinjeopardyifResolution37isapproved.
Q.7.WhatCEopportunitiesareavailabletomeethisnewguideline?
CDEL’sCLAIMS:
• TheCouncilsaysitis“aware”ofatleast11CEcourseswithahands-oncomponentthat“may”offerthecoursecontentanddurationasproposedinResolution37.
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CDELaddsthatitis“confident”thatprovidersofCEonthesubjectofsedationandanesthesiawillenrichtheireducationalofferingstocomplywiththenewguidelines,shouldResolution37beapprovedbythe2016HOD.
CDELgoesontolistthe11courseproviders,includingnon-profitandfor-profiteducators.
THEFACTS:
• GiventhatResolution37,ifapprovedwillrequirethetrainingorretrainingoftensofthousandsofdentists,CDEL’sobviouslackofhardresearchtobackits“confidence”thatcoursesexistorwillbecreatedtomeettheeruptivenewdemandishighlyquestionable.NordoesCDELweighinonthequestionhere,oranywhereinitsFAQ,ofhowmuchsuchcourseswillcost,howmanydaysawayfromtheirpracticedentistswillneedtotaketofulfillthecourserequirements,whattravelexpenseswillbenecessarytoattendthecourses,andwhatdentistsshoulddowhentheyareunabletofindavailableseats.[ForMore,SeeQuestion#12andtherelatedFACTCHECK.]AsnotedintheFACTCHECKforQuestion#2,the8verifiedCEcoursesthatCDELreferences(outofthe11CDELerroneouslylisted)refertoexistingeducationalprogramsaimedexclusivelyatlicensingrequirementsfordentistswhowillprimarilyprovideparenteralsedation.Therearefewerthan150seatsperyearavailablenationwidetodentistswhoseektoacquiresuchparenteralsedationtraining.Moreover,thecoursesareNOTdesignedtopreparedentiststoprovideenteralsedation.Therearenoknowncoursesofferedbyanycredibleeducationalinstitution,for-profitornonprofit,thatprovide60hoursofdidactictrainingand20livecasestothosedentistswishingonlytobecertifiedtoprovidemoderateenteralsedation.CDELmadenoefforttoexplainwhat,specifically,courseprovidersshouldteachduringthe36hoursofadditionaldidactictrainingthatResolution37wouldrequire.(Neithertheadditionaltrainingnecessarytooperatecapnographyequipment,northeadditionalfocusonrescuingpatientsfromalevelofsedationdeeperthanintended,requires36hoursontopofthe24hourscurrentlyrequiredby
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existingADAguidelines,veterandentaleducatorspointout.Formoreinformation,seethetranscriptoftheNationalDentalTownHallheldonOctober10,2016,featuringapaneloffourdentalluminaries.Thetranscriptisavailableat:http://tinyurl.com/Dionne-Transcript.)CONCLUSION:Therearenotandwillnotbesufficientcourses(fordecadestocome)tomeettheneedsofthedentalprofession,shouldResolution37anditsstrictersedationpermitrequirementsbeapproved.CDEL’s“confidence”isnotbasedonathoroughinvestigationofthecapabilitiesofCEproviders.
Q.8.IprovidedcommenttoCDEL;whywasmyadviceoverlooked?
CDEL’sCLAIMS:
• TheCouncilanswersthatwhileit“didnotagreewithallpointsmade,”allinputwassystematicallyreviewedandconsidered.
Inresponsetothefeedbackitreceived,theCouncilacknowledgesthat“themajorityofevidence”itreliedoncameintheformofexpertopinion.
Itfurtherexplainsthat“notonecontrolledclinicalstudyhaseverbeenperformedtodemonstratetheoptimaltrainingtimefordentistswhoprovidemoderatesedation,”addingthatsuchastudy“maybenearlyimpossibletofundorconductortobeclearedbyaninstitutionalreviewboard.”CDELpointstoitsowncouncilmembers’“expertiseincontemporaryeducationalprinciples,”adding,“WerelyonourAnesthesiologyCommitteeexperts…toevaluateanesthesiologyinformationandprovideCDELwiththebestrecommendations.”
THEFACTS:
Whiletherearenotrandomizedcontrolledtrialsorpublished,peer-reviewedstudiesthatbearoneverysingleaspectofADAResolution37,thereare–contrarytoCDEL’sassertion–numerousscientificandevidence-basedjournalarticlesdetailingresearchthatcontradictsCDEL’sposition.
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See:http://GetTheScience.comtoreviewjustsomeofthepublished,peer-reviewedarticlesonthistopic.Also,notethecitationsofotherrelatedresearchatthebottomofeacharticlepostedatGetTheScience.com.CDELfailstoprovidecitationsorreferencestopublished,peer-reviewedstudiesthatsupportthemajorassertionscontainedinResolution37.
• CDELoffersnoexplanationforhow–intheadmittedabsenceofevenonecontrolledclinicalstudy–itsettledonResolution37’s250%increaseintherequirednumberofdidactichoursthatwillgoverndentistswishingtoprovidemoderateenteralsedation,shouldthe2016HODapprovethenewguidelines.[Resolution37alsoincreasesthenumberofcasesrequiredtobecertifiedformoderateenteralsedationby100%andlivecasesby667%.]
• CDELpresentszeroevidencesubstantiatingthatthecurrentADAguidelines,adoptedbythe2007and2012HOD,areinadequatetoprovideforpatientsafety.
• CDELindicatesthatitfavoredtheexpertopinionsofitsownmembersandmembersofCDEL’sAnesthesiologyCommitteeoverthoseofotherexpertsandorganizationsthatsubmittedtestimonyandwrittencommentsopposedtoResolution37.
Doingso,onceagain,fliesinthefaceoftheADA’s“PolicyonEvidence-BasedDentistry,”whichdoesnotplacetheexpertiseofADAmemberswhoareappointedtovariousADACouncilsandCommitteesaheadofscience,peer-reviewedresearch,theclinicalexperienceofdentists,orthetreatmentneedsandpreferencesofpatients.ServiceonADACouncilsandCommitteesisvitaltotheorganizationbutdoesnotconfersuperiorknowledgeorexpertiseonCouncilandCommitteemembers.• AmongthosewhoseexpertviewsandclinicalexperienceCDELconsidered
butfeltsufficientlycompetenttoignoreinpartorinfullare:
o AcademyofGeneralDentistryrepresentingmorethan40,000dentists,includingthelargestnumberofdentistsofanydentalgroup(otherthantheADA,itself)thatalreadyusemoderateenteralsedationintheirpractices.
o AmericanAcademyofPediatricDentistryrepresenting9,900memberswhoserveasprimarycareandspecialtyprovidersformillionsofchildren
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frominfancythroughadolescence.
o AmericanDentalSocietyofAnesthesiologyrepresenting5,000memberswhoprimarilyengageinthepracticeofanesthesiologyindentistry,eitherlocalorgeneral.
o AmericanSocietyofDentistAnesthesiologistsrepresentingapproximately4,500dentistswhohavecompletedaminimumoftwoyearsoffull-timepostdoctoraltrainingindentalanesthesiology.
o DOCSEducation,whichhastrainedmorethan20,000dentistsinsedationdentistrytechniquesthatcomplywithexistingADAguidelinesandstateregulations.Morethan20millionAmericanshavereceivedcarefromDOCSEducation-traineddentists,whoconformtothecurrentADAGuidelines,withoutincident.
o RicklandG.Asai,DMD,11thDistrictADATrusteerepresentingAlaska,Idaho,Montana,Oregon,andWashington.Dr.Asai,anadvocateforaccesstoaffordabledentalcare,isoneofeightADATrusteeswhoinAugust2016votedagainstallowingResolution37tocomebeforethe2016HOD.
o TheCaliforniaDentalAssociationrepresentedbyGayleMathe,CDAPublicAffairs.
o IdahoStateDentalAssociationrepresentedbySusanMiller,executivedirector,andJohnE.HiselJr.,DDS.
o TexasAcademyofGeneralDentistryrepresentedbyBrookeElmore,DDS,FAGD,TAGDAdvocacyCouncilChair.
o Dr.MarkWalker,chairofaneight-membertaskforceorganizedbyDr.LindaWilliamsandcomposedofrepresentativesfromeachofthefivestatesinADADistrictXI.Dr.Williams,CaucusChair,ADADistrictXI,submittedseparatewrittencommentstoCDEL.
o RaymondDionne,DDS,PhD,aleadingpainscientistanddentaleducatorwhohaspublishedmorethan100scientificmanuscriptsrelatedtohisworkonpainandpaincontrol.Hiscareerincludesmorethan20yearsofprivatepracticeexperienceandmorethan30yearsofclinicalresearch.HewasaninvestigatorintheNationalInstituteofDentalandCraniofacialResearchfor25years,wherehealsoservedasChiefofthePainandNeurosensoryMechanismsBranchandClinicalDirector.
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o FredQuarnstrom,DDS,FASDA,FAGD,FICD,FACD,CDC,whohastaught253nitrousoxidesedationcoursesand117oralconscioussedationcourseswithorwithoutnitrousoxidesedation.Dr.Quarnstromhaspublishedmorethan50papersonsedationandwrittenchaptersinthreebooksonfearandpaincontrol.
o AnthonyCarroccia,DDS,MAGD,ABGD,ageneraldentistwhopossessesaComprehensiveConsciousSedationPermitinTennesseeandservesontheTDACommitteeforAnesthesia,SedationandScopeofPractice.Dr.Carrocciateachesnitrousoxide-oxygenmonitoringcoursestoassistantsandadministrationtohygienists.In2009,Dr.CarrocciawasnamedtheNationalSedationSafetyDentistoftheYear.
o MartinElson,DDS,ImmediatePastPresidentoftheRhodeIslandOralandMaxillofacialSurgeonsandChristyD.Durant,Esq.,LegalCounselfortheRhodeIslandOralandMaxillofacialSurgeons.
o RockyL.Napier,DMD,FACD,FICD,FPFA,amemberoftheAmericanAcademyofPediatricDentistryandAmericanAcademyofPediatrics,andPresident-ElectoftheSouthCarolinaDentalAssociation.Dr.Napierprovidedmorethan$640,000offreeanduncompensatedcarein2015alone.
CONCLUSION:CDEL’srelianceonitsownmembers,membersappointedtoitsAnesthesiologyCommittee,andhand-selectedoutsideexpertsraisesimportantquestionsofbias.WhydidCDELgivetherecommendationsofcertainindividualsandgroupslegitimacytothetotalorpartialexclusionofotherclearlyqualifiedexpertsandorganizations,suchasthoselistedabove?CDELoffersnospecificswhatsoeveraboutwhatits“systematic”evidentiaryreviewprocessconsistedof,nordoesitprovideadetailedlistofpublishedcitationstosupportisconclusionsandrecommendations.ThelackoftransparencyinCDEL’sprocess–especiallyafterinvitingpubliccommentandtestimony–underminestheCouncil’scredibility,andcallsintoseriousquestionthescientific,evidence-basedvalidityofResolution37.
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Q.9.Whyisthenewdefinitionofoperatingdentistproposed?
CDEL’sCLAIMS:
• TheCouncilsaysthatchangingthedefinitionto“operatingdentist”from“qualifieddentist”–asproposedinResolution37–isintendedtobringclarityinthefaceofsomestatelegislaturesandregulatorswhohavesetspecificdefinitionspertainingtotheclinicaloperativedentistwhoworkswithananesthesiaprovider.CONCLUSION:ThisisachangethatappearsbenignandunlikelytoimpactADAmembersortheirpatients.IftheredefinitionwasproposedseparatelyfromtheotherprovisionsofResolution37,itisunlikelythenewterminologywouldfacemeaningfulopposition.
Q.10.HowmanystatescurrentlyrequiredentiststomonitorexpiredCO2viacapnographyduringmoderatesedation?
CDEL’sCLAIMS:
• TheCouncilnotesthatatleast15states“mention”capnographyintheirlawsorindentalboardpolicyformoderatesedation,“eitherasarequirement,amonitoringoption,orasaproposedregulation.”
THEFACTS:
• CDELcouldhave,butchosenotto,describealongwitheachofthe15statesitciteswhetherthementionsarespecificallyaboutmonitoringasarequirement,option,orproposal.Itmakesadifference,especiallyinclarifyinganissueascontentiousasResolution37.
GivenCDEL’sopenadvocacyforResolution37,itissafetoassumethatifamajorityofthe15statesnotedbyCDELcurrentlyrequirecapnography,CDELwouldhavesaidasmuch.
CONCLUSION:Thirty-fivestatesdoNOTcurrentlyevenmentioncapnographyasamonitoringoption.Moreover,CDELfailstoinformADAmemberswhichstate
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orstatesabsolutelyrequireit.CDEL’slackoffulldisclosureonthismattersmacksmoreofapanelofbiasedadvocatesthananimpartialcouncilofexpertstryingtopresentunbiasedfactstothe2016HOAandotherADAmemberssothattheycanmakeaninformeddecision.
Q.11.Whatistheapproximatecostofacapnography?Q.12.Willthesenewguidelinesincreasethecostofdentalcareordecreaseaccesstocareforsomepatients?
CDEL’sCLAIMS:
• TheCouncilstates,“ingeneral,acapnographcanrangeinpricefrom$800-$3,000.”[Question11]
CDELthencitesitsownestimatetoconclude,“Theequipmentneededtomonitorend-tidalCO2shouldnotappreciablyincreasethecostofdeliveringmoderatesedationordecreaseitsavailabilitytopatients.”[Question12]CDELlabelsthe$800-$3,000equipmentcostas“areasonableinvestmenttoidentifymorerespiratorycomplicationsandsupportriskmanagementandpatientsafety.”
• CDELstatesunequivocally,“Thereisnoevidence*demonstratingthatthecostofcarewillincrease,thatpatientaccesstosedationwilldecreaseorthatthenumberofsedationpermitswilldecrease”shouldthe2016HODapproveResolution37.
THEFACTS:
• CDELdeliberatelyignoresthesalientfactthatthecostofcapnographyequipmentistheleastonerousofthecostsassociatedwithResolution37.ShouldResolution37beapprovedbythe2016HOD,dentistswhowishtoprovidetheirpatientsmoderateenteralsedationwillhavetobuythecapnographyequipment;trainthemselvesandtheirteamonitscorrectusage;paytuitiontoenrollina60-hourcoursetoqualifythemtoprovidemoderateenteralsedation;beawayfromtheirpracticeforanextendedtimeto
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completethecourseanditsrequirementtoparticipatein20livetrainingcases;andpayfortravel,meals,andhotelshouldthecoursebeofferedinan‘away’venue. CDELalsodoesnotcalculatethecoststodentistsofbeingunabletoprovidemoderateenteralsedationtopatientsifthedentistsareunabletoenrollinacourseonatimelybasis,eitherduetothedentists’ownschedulingconflicts,orthelackofavailabilityofsufficientCEproviders.
• CDELcanonlyclaim*that“thereisnoevidencedemonstratingthatthecostofcarewillincrease”becauseitmadenoeffortin2015or2016toconductevenasuperficialeconomicimpactstudytodeterminetherealcostsofResolution37todentists,andhowthosecostswillbepassedalongtopatients.WhiletheADA’smission,since1859,hasbeentobea“patient-centered”association,CDEL’sassertion–withoutoneiotaofsupportingevidence–thatResolution37willnotimpactthecostoravailabilityofcaredishonorsthatmissionstatement.Oneneedn’tbeaneconomisttounderstandthatwhendentistsarerequiredtoinvestheavilyinadditionalout-of-officeeducation–suchasrequiredbyResolution37,impacteddentistswillneedtofindawaytorecouptheirexpensesandlostproduction.Charginghigherfees,withtheconcomitantburdenthatplacesonpatients,iscertaintoreduceaccesstocare.GivenResolution37’srequirementsthatincreasethenumberofdidactichoursrequiredtoprovidemoderateenteralsedationby250%;thenumberofcasesby100%;andthenumberoflivecasesby667%;itisonlylogicaltobelieve–despiteCDEL’sunsupportedcontention–thatmanydentistswillopt,instead,tosimplystopobtainingsedationpermits.*In2015andagainin2016,TEAM1500issuedasummaryofitsowneconomicimpactstudyforecastingtheeffectondentistsandpatients,shouldADAResolution37(originallycalledResolution77)beapproved.ThestudywasconductedbetweenJuneandSeptember2015,drawingondataandcalculationsobtainedfromacross-sectionofpracticingoralhealthcareprofessionals,dentalschoolacademics,regulatoryexperts,andfinancialforecasters.ThestudywasheadedbyDeanRotbart,aPulitzerPrize-nominatedfinancialjournalistandformerinvestigativereporteratTheWallStreetJournal.
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AmongTEAM1500’sfindings:
o Higherdentalfeesandlongerwaittimestoseeaqualifieddentistwilldrivepatientsawayenmasse.Withinfiveyears,anestimated250,000patientswhocurrentlyvisitadentistonaregularbasiswillstopgoing.
o ThecostoftrainingrequiredbyResolution37willrunashighas$50,000ormoreperdentist,whentuition,travel,andlostproductivityareincluded.
o Thetotalnumberofdentistsavailabletoprovidesedationdentistrywill
declineby5%to7%annually,factoringintheretirementandattritionofexistingdentists.Withinfiveyears,thenumberofgeneraldentistswhoarequalifiedtoprovidemoderateenteralsedationcoulddeclinebymorethan30%nationwide.
TEAM1500,formedin2006,advocatesonbehalfofpatientsandaccesstoaffordablehealthcare.TEAMisanabbreviationofTrustforEqualAccessMedicine.Thegroupisacoalitionofmorethan1,500healthcareprovidersandothersconcernedwithpatients’rights.
CONCLUSION:CDEL’sfocusonthecostofcapnographyequipmentinthesetwoFAQquestionsisaformofmisdirection.Itisthetrainingcosts,lostproduction,andrelatedtravelexpensesthatneedconcerndentists,notonlyfortheirowneconomicwell-beingbutalsoforthefinancialwell-beingoftheirpatients.
CDEL’scontentionthat“thereisnoevidence”demonstratingtheeconomicimpactondentistsandtheirpatientsignoresathree-monthindependentanalysisundertakenbyaformerWallStreetJournalreporterandapatients’rightsgroup.In2015and2016,CDEL,itself,madenoeffortwhatsoevertoconductastudytogaugethelikelyimpactofResolution37onpatients.
Q.13.WhenandwhyweretheSedationandAnesthesiaGuidelinesdeveloped?
CDEL’sCLAIMS:
• TheCouncilstatesthattheGuidelines,whichhavebeenrevisedtentimessincetheywerefirstestablishedin1971,areintendedto“assistdentistsinthedeliveryofsafeandeffectivesedationandanesthesia.Therevisions“reflectemergingpracticeandscientificprinciples.”
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THEFACTS:
• TheexistingADAGuidelinesgoverningtheuseandteachingofsedationandanesthesiawerelastsignificantlyrevisedin2007andapprovedbythe2007HOD.(In2012,theGuidelineswereminimallyrevisedagainbytheHOD.)Incompliancewiththe2007/2012Guidelinesandapplicablestateregulations,tensofmillionsofpatientshavereceivedmoderateenteralsedationtreatmentssafely,effectively,andwithoutincident.The2007/2012Guidelines,inaccordancewiththestatedpurposeforsuchguidelines,doreflectemergingpracticeandscientificprinciplesandarewidelysupportedbythedentistswhoregularlyadministermoderateenteralsedation.
• TherevisionstotheuseandeducationguidelinesproposedinResolution37,unlikethoseadoptedin2007/2012,doNOTreflectemergingpracticeandscientificprinciples–andtheyareopposedbyvirtuallyalldentistswhoactuallyadministermoderateenteralsedationtopatients.Moreover,thereisnosupportivesciencewhatsoeverforthepreponderanceoftherecommendedrevisions,andCDELhasnotproducedanysupportiveevidence-basedresearchtosubstantiateitsrecommendedGuidelinerevisions.TheexistingpracticeandclinicalevidencepertainingtosedationandanesthesiaoverwhelminglynegatetheneedforResolution37.TherevisionscontainedinResolution37wereconceivedanddraftedbyoralsurgeons,academics,andotherADAspecialistswhodoNOTprovidepatientsmoderateenteralsedation.TheseCouncilandCommitteemembersdonotqualifyasrepresenting“emergingpractice”clinicians.CONCLUSION:CDEL’scharteristoupdatetheADA’suseandteachingguidelinesforsedationasneeded.InResolution37,CDELhasproposedbroadunneeded,unjustified,andscientificallyunsoundchangestotheexistingADA2007/2012Guidelinesthathaveproven–aboveandbeyonddispute–toprotectpatientswhendentistsadministermoderateenteralsedationinaccordancewiththeexistingGuidelines.
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Q.14.WhatistheprocessforproposingrevisionstotheHouseofDelegates?
CDEL’sCLAIMS:
• TheCouncilnotesthatinkeepingwithadirectivefromtheHouseofDelegates,itreviewstheADA’ssedationandanesthesiaguidelineseveryfiveyears.Itcites“changesinpracticeandscience”toexplainthereasonstheguidelineshaverecentlybeenupdatedmorefrequently.CDELnotesthatalongwithitsAnesthesiologyCommittee,itsseeksinputfromthe“anesthesiacommunitiesofinterest.”ItfurtherexplainsthatitsAnesthesiologyCommittee,whichcarefullystudiestheissuesandprovidestechnicalandscientificinputtoCDEL,includes“representativesfrom”:
o AmericanAcademyofPeriodontologyo AmericanAssociationofOralandMaxillofacialSurgeonso AmericanDentalSocietyofAnesthesiologyo AmericanSocietyofDentistAnesthesiologistso AmericanSocietyofAnesthesiologistso AmericanAcademyofPediatricDentistry
Thisyear,CDELadds,amemberoftheADA’sCouncilonScientificAffairsalsoparticipatedincommitteemeetings.CDELwritesthatit“considerstheCommittee’srecommendationsandcirculatesproposedrevisionstoitsdentalanesthesiologycommunitiesofinterest.”
THEFACTS:
• ThecompositionofCDELanditsAnesthesiologyCommitteeisheavilyweightedtowardoralsurgeonsandotherspecialists,andgreatlyunderrepresentedbygeneraldentistsandthosewhoregularlyusemoderateenteralsedationinaclinicalsetting.
ThereisnomandatefromtheHouseofDelegatestoexcludegeneraldentists.NordoestheHODdictatethatinconsideringitsactions,CDELshouldonlyrelyon“dentalanesthesiologycommunitiesofinterest.”ThedominanceofspecialistsontheCommitteewarpstheobjectivityoftheentireprocess.Thelackoftransparency,especiallyasitpertainstothespecific
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changesin“practiceandscience”thatCDELcites,invitesquestionsastowhetherCommitteemembersareactingsolelyinthebestinterestsofpatientsafety.
• CDEL’swordingmightbeinterpretedtoindicatethattheAnesthesiologyCommitteeiscomprisedofdesignated“representativesfrom”thevariousanesthesiologygroupsitslists–meaningthattheoutsidegroupsselectedamembertorepresentthem.It’sunclearifthisisthecase.
AnotherinterpretationofCDEL’swordingisthatmembersoftheAnesthesiologyCommitteearealsomembersofthevariousoutsideanesthesiologyassociations,butnotofficiallydesignatedrepresentativeofthosegroups–andwithoutanysuchofficialstanding.
• The800-poundgorillaintheroom,whichCDELfailstoaddressinitsresponsetothisquestionandthroughoutits15-QuestionFAQ,iswhyCDELisfocusingon,andmakingrecommendationspertainingto,moderateenteralsedation,whentheoverwhelmingmajorityofdentalfatalitiescitedinthegeneralnewsmediaoverthepastdecadehavetakenplaceinpracticesusingdeepsedation/generalanesthesia–notmoderateenteralsedation.Ifthereisanyareaofdentistrythatcriesoutforcloserscrutinyandpossiblystrictertrainingandpracticeguidelinesitisdeepsedation/generalanesthesia.Oralsurgeryisthesoledisciplineinallfieldsofmodernmedicinethatallowsdoctorstoadministerdeepsedation/generalanesthesiawhilealsoperformingtheprocedure.LegislatorsinCaliforniaunanimouslyapprovedabillinAugust2016,popularlyknownasCaleb’sLaw,thatspecificallywouldestablishacommitteetostudythesafetyofpediatricanesthesia.Thebill’ssponsorshavestatedthattheyfindit“disconcerting”thatoralsurgeonsarenotrequiredtotreatpatientsusingaseparateanesthesiaprovider.Caleb’sLawdoesnotconcernmoderateenteralsedation.YetCDELanditsAnesthesiologyCommittee,comprisedprimarilyoforalsurgeons,doesnotevenraisetheissuesthatareatthecenterofCaleb’sLawandtragediesimpactingdentalvictimsinoralsurgeons’officesnationwide.Why?
CONCLUSION:CDELdoesnotappeartobeactinginthebestinterestsofalldentistsandtheirpatientsasitsonlypriority.CDEL’sarbitraryinclusionofsomeexpertsandevidence,andexclusionofothers,taintsitsrecommendationsandconclusions.
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Themostseriousissuefacingprofessionaldentistryandpublicsafetysurroundsdeepsedation/generalanesthesia–notmoderateenteralsedation.TheverycredibilityoftheADAasachampionofevidence-basedscienceandpublichealthisthreatenedbyCDEL’sactionandtheduplicityofResolution37.
Q.15.WhatinformationwasusedtodeveloptheproposedrevisedGuidelines?
CDEL’sCLAIMS:
• TheCouncilrespondsthatitsCommitteeonAnesthesiology“reliedoncurrentstandardsofcare,guidelinesofothermedicalanddentalorganizations,thescientificliterature,currentstateregulationsforsedation,andtheexpertiseofpractitioners,academiciansandstatedentalboardmembers…”
THEFACTS:
• Tensofthousandsofdentistsregularlyusemoderateenteralsedationintheirpractices,inaccordancewithexistingADAguidelinesandfullcompliancewithstateregulations,safelyandwithoutincident.TheexpertsthattheCommitteeonAnesthesiologyandCDELreliedupon,withscantfewexceptions,havelittleifanyexperiencewithmoderateenteralsedation.Asaresult,asmallgroupof“textbook”expertsisattemptingtodictatetoamultitudeofADAmemberswithsubstantialclinicalexperiencehowtobestprotecttheirpatients.
Anyefforttoreflexivelyimposesedationstandardsfromthemedicalcommunityonthedentalcommunityismisguided.Dentistryhasalonganddistinguishedrecordofsettingthestandardforsafe,effective,sedationandanesthesia.Manydentalsedationstandards,includingthecommonuseofNitrousOxide,donotconformtomedicalstandards.Likewise,dentistrystandsaloneamongallmedicalfieldsinpermittingasingledentisttoadministerdeepsedation/generalanesthesiawhilealsoperformingtheprocedure.AmongalltheexpertsCDELcites,notasinglegrouprepresentingthosewhoregularlyusemoderateenteralsedationsupportsResolution37ormaketheargumentthatrevisionstotheexistingADAsedationguidelinesareessentialtoprotectpatientsafety.
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Thoughit’sdoubtfulthatCDELintendstoinsultthelargegroupofdentistswhocurrentlyusemoderateenteralsedationintheirpractices,CDELignoresthetruth:ThesededicateddentistswhousemoderateenteralsedationwouldbetheveryfirsttodemandchangesintheexistingADAguidelinesiftheyfelttheirpatientswereatrisk.
• CDELassertsthat“currentstandardsofcare,”“thescientificliterature,”and“currentstateregulations”areamongthesourcesthattheCommitteeonAnesthesiologyanditreliedon.
Wefindnoobjectiveevidencetosupporttheassertionthatthesethreesources,inparticular,offervalidationoftherevisionsproposedinResolution37.Onlythoseexpertswhodon’tprovidetheirpatientswithmoderateenteralsedation–andhavenoprofessionalexperienceadministeringit–appearconvincedthattheexistingguidelinesgoverningthiscommonformofsedationareinsufficient.
CONCLUSION:CDELfailedtoweighorplacesufficientweightonthevastclinicalexperiencesofthetensofthousandsofdedicateddentistswhoregularlyusemoderateenteralsedationintheirpractices.Instead,theCouncilturnedto“textbook”expertswhoseemcompelledtorecommendthechangesproposedinResolution37forchangesakealone.ThereisnopublichealthcrisisinenteralsedationdentistryandnocompellingneedforResolution37.
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